Menthol versus tobacco e-liquid flavor: Impact on acute subjective effects, puff patterns, and intentions for use among Black and White menthol smokers.

BACKGROUND: The proposed FDA product standard to prohibit menthol as a characterizing flavor in combustible cigarettes has the potential to significantly reduce tobacco-related health disparities. Whether a menthol e-liquid product standard would improve or hinder public health is unknown. No known research has directly examined the impact of menthol vs. tobacco flavored e-liquid use on acute e-cigarette use patterns, subjective experience, behavioral intentions, and craving and withdrawal among menthol cigarette smokers. METHODS: Black (n = 47) and White (n = 4) nicotine-deprived menthol smokers with limited e-cigarette experience completed two counterbalanced in-laboratory 30-minute ad libitum vaping sessions with menthol and tobacco nicotine salt-based e-liquid in a randomized crossover pilot trial design. Questionnaires assessed reductions in craving and withdrawal and post-session subjective experience and behavioral intentions. Puff topography was measured continuously throughout each vaping session. RESULTS: Measures of puff topography did not differ significantly by e-liquid flavor (all p > .40). Similarly, menthol and tobacco flavored e-cigarettes were both rated positively in terms of subjective effects and behavioral intentions (all p > .10) and about 40 % of participants reported a preference for the tobacco-flavored e-liquid. Finally, participants showed comparable reductions in craving (p = .210) and withdrawal (p = .671) from pre- and post-session regardless of e-liquid flavor. CONCLUSIONS: Among menthol smokers in a lab-based setting, findings suggest that menthol vs tobacco e-liquid flavor has little impact on acute changes in puff patterns, subjective experience, behavioral intentions, or craving and withdrawal.

Using pod based e-cigarettes and nicotine pouches to reduce harm for adults with low socioeconomic status who smoke: A pilot randomized controlled trial.

INTRODUCTION: Alternative Nicotine Delivery Systems (ANDS) such as e-cigarettes (EC) and oral nicotine pouches (ONP) may facilitate the substitution of smoking for those unwilling to quit. This pilot study assesses the harm reduction potential of EC and ONP among smokers with low socioeconomic status (SES). METHODS: Adults who smoked daily in the past 6 months, had a household income < 250% federal poverty level and had no intention of quitting smoking in the next 30 days were randomized 2:2:1 to 8 Weeks of 5% nicotine EC; 4mg ONP or assessment-only control (CC). The primary outcome was a within-group change in cigarettes per day (CPD) from Baseline to Week 8. RESULTS: 45 individuals were randomized (EC: N=18; ONP: N=18; CC: N=9). Analyses included 33 participants who completed the Week 8 visit. Mean age was 50.2 years (SD:10.7) and average CPD at baseline was 13.9 (SD: 10.1). For those randomized to EC, average CPD decreased from 14.7 (95%CI: 10.3; 19.1) at Baseline to 2.9 (95%CI: 0.09; 5.79) at Week 8 (p-value <0.001). For those randomized to ONP, average CPD decreased from 15.0 (95%CI: 5.02; 24.93) to 8.3 (95%CI: 1.34; 15.18) by Week 8 (p-value =0.01). In the EC and ONP groups, respectively, 4 (28.6%) and 1 (8.3%) participant fully switched from smoking to the ANDS product by Week 8. CONCLUSIONS: Individuals with low SES who smoke had lower CPD after switching to EC or ONP. These findings show the potential of ANDS in helping smokers switch to less harmful devices. IMPLICATIONS: This study provides novel evidence that e-cigarettes and nicotine pouches can be a harm reduction tool for individuals with lower SES who smoke and are not willing to quit smoking, contributing to reducing tobacco-related disparities in this population.

Nicotine Delivery and Changes in Withdrawal and Craving During Acute Electronic Cigarette, Heated Tobacco Product, and Cigarette Use Among a Sample of Black and White People Who Smoke.

INTRODUCTION: E-cigarettes and heated tobacco products (HTPs) may serve as potential options for harm reduction for smokers if they possess reward profiles similar to cigarettes. Little is known about the abuse liability of HTPs and e-cigarettes versus cigarettes in racial/ethnic minority smokers. AIMS AND METHODS: Twenty-two nicotine-deprived people who smoke (black [n = 12] and white [n = 10]) completed three visits that included a standardized 10-puff bout followed by a 50-minute ad libitum use assessment with their usual brand cigarette (UBC), an e-cigarette, and HTP. Visits were completed in a randomized crossover design and were separated by a minimum 48-hour washout period. Assessments included plasma nicotine, Cmax, and reductions in craving and withdrawal. RESULTS: UBC delivered significantly greater levels of nicotine compared to the e-cigarette (p < .001) and HTP (p < .01) during both the standardized and ad libitum sessions. HTP delivered more nicotine than the e-cigarette during the standardized puffing session (p = .047) but not the ad libitum session. Only craving during the standardized puffing session and not the ad libitum session showed significant differences across products (p < .001) such that UBC resulted in the greatest reduction followed by HTP and e-cigarette. CONCLUSIONS: Despite greater nicotine delivery from the UBC compared to e-cigarette and HTP, participants reported reductions in craving and withdrawal across products, particularly following ad libitum use. IMPLICATIONS: Use of participant's UBCs (UBC) resulted in greater nicotine delivery compared to both the e-cigarette and HTP. Despite this relative difference in nicotine delivery, participants reported reductions in craving and withdrawal across products, particularly following ad libitum use. These findings suggest that in this sample of black and white people who smoke, HTPs and e-cigarettes provided significant relief from negative symptoms that maintain smoking.

The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial.

INTRODUCTION: People who smoke cigarettes are more likely than people who do not to use cannabis, including blunts, a tobacco product containing nicotine and marijuana. Blunts represent a challenge for cessation trials because nicotine could make stopping cigarettes more difficult. Few studies have examined the impact of blunt use on individuals actively engaged in a cigarette quit attempt. METHODS: Blunt use was assessed at baseline, Weeks 4, 8, 12, 16, and 26 among Black adult people who smoke enrolled in a double-blind, placebo-controlled, randomized trial of varenicline (VAR, n = 300) versus placebo (PBO, n = 200) for smoking cessation. Participants were categorized as ever blunt (blunt use reported at any timepoint) versus non-blunt (no blunt use reported). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at Weeks 12 and 26. Logistic regression examined the effects of treatment and blunt use on abstinence. RESULTS: 75 participants (mean age 45.6 years (SD = 12.5, range: 22,80); 32 (42%) female) reported blunt use. Logistic regression analyses showed no treatment by blunt use interaction or significant main effect of blunt use on smoking abstinence at Weeks 12 or 26 (p > 0.05). After adjusting for treatment, those who used blunts had statistically similar odds of quitting at Week 12 (OR: 0.68, 95% CI: 0.31, 1.5) and Week 26 (OR: 0.84, 95% CI: 0.38, 1.87) as those who never used blunts during the study. DISCUSSION: Blunt use had no statistically significant impact on cessation among participants in a smoking cessation clinical trial. Future trials are needed in which the target of cessation is all combustible products.

Early Treatment Response in Black Smokers Undergoing Pharmacotherapy for Smoking Cessation: A Secondary Analysis of a Randomized Clinical Trial.

This secondary analysis of a randomized clinical trial investigates the association of early treatment response with smoking cessation among Black smokers.

Evaluating Work Impairment as a Source of Financial Toxicity in Cancer Healthcare and Negative Impacts on Health Status.

How the socioeconomic factors intersect for a particular patient can determine their susceptibility to financial toxicity, what costs they will encounter during treatment, the type and quality of their care, and the potential work impairments they face. The primary goal of this study was to evaluate financial factors leading to worsening health outcomes by the cancer subtype. A logistic model predicting worsening health outcomes while assessing the most influential economic factors was constructed by the University of Michigan Health and Retirement Study. A forward stepwise regression procedure was implemented to identify the social risk factors that impact health status. Stepwise regression was done on data subsets based on the cancer types of lung, breast, prostate, and colon cancer to determine whether significant predictors of worsening health status were different or the same across cancer types. Independent covariate analysis was also conducted to cross-validate our model. On the basis of the model fit statistics, the two-factor model has the best fit, that is, the lowest AIC among potential models of 3270.56, percent concordance of 64.7, and a C-statistics of 0.65. The two-factor model used work impairment and out-of-pocket costs, significantly contributing to worsening health outcomes. Covariate analysis demonstrated that younger patients with cancer experienced more financial burdens leading to worsening health outcomes than elderly patients aged 65 years and above. Work impairment and high out-of-pocket costs were significantly associated with worsening health outcomes among cancer patients. Matching the participants who need the most financial help with appropriate resources is essential to mitigate the financial burden. Significance: Among patients with cancer, work impairment and out-of-pocket are the two primary factors contributing to adverse health outcomes. Women, African American or other races, the Hispanic population, and younger individuals have encountered higher work impairment and out-of-pocket costs due to cancer than their counterparts.

Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial.

Importance: Adapting to different smoking cessation medications when an individual has not stopped smoking has shown promise, but efficacy has not been tested in racial and ethnic minority individuals who smoke and tend to have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Objective: To evaluate efficacy of multiple smoking cessation pharmacotherapy adaptations based on treatment response in Black adults who smoke daily. Design, Setting, and Participants: This randomized clinical trial of adapted therapy (ADT) or enhanced usual care (UC) included non-Hispanic Black adults who smoke and was conducted from May 2019 to January 2022 at a federally qualified health center in Kansas City, Missouri. Data analysis took place from March 2022 to January 2023. Interventions: Both groups received 18 weeks of pharmacotherapy with long-term follow-up through week 26. The ADT group consisted of 196 individuals who received a nicotine patch (NP) and up to 2 pharmacotherapy adaptations, with a first switch to varenicline at week 2 and, if needed, a second switch to bupropion plus NP (bupropion + NP) based on carbon monoxide (CO)-verified smoking status (CO ≥6 ppm) at week 6. The UC group consisted of 196 individuals who received NP throughout the duration of treatment. Main Outcomes and Measures: Anabasine-verified and anatabine-verified point-prevalence abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points). The χ2 test was used to compare verified abstinence at week 12 (primary end point) and weeks 18 and 26 (secondary end points) between ADT and UC. A post hoc sensitivity analysis of smoking abstinence at week 12 was performed with multiple imputation using a monotone logistic regression with treatment and gender as covariates to impute the missing data. Results: Among 392 participants who were enrolled (mean [SD] age, 53 [11.6] years; 224 [57%] female; 186 [47%] ≤ 100% federal poverty level; mean [SD] 13 [12.4] cigarettes per day), 324 (83%) completed the trial. Overall, 196 individuals were randomized to each study group. Using intent-to-treat and imputing missing data as participants who smoke, verified 7-day abstinence was not significantly different by treatment group at 12 weeks (ADT: 34 of 196 [17.4%]; UC: 23 of 196 [11.7%]; odds ratio [OR], 1.58; 95% CI, 0.89-2.80; P = .12), 18 weeks (ADT: 32 of 196 [16.3%]; UC: 31 of 196 [15.8%]; OR, 1.04; 95% CI, 0.61-1.78; P = .89), and 26 weeks (ADT: 24 of 196 [12.2%]; UC: 26 of 196 [13.3%]; OR, 0.91; 95% CI, 0.50-1.65; P = .76). Of the ADT participants who received pharmacotherapy adaptations (135/188 [71.8%]), 11 of 135 (8.1%) were abstinent at week 12. Controlling for treatment, individuals who responded to treatment and had CO-verified abstinence at week 2 had 4.6 times greater odds of being abstinent at week 12 (37 of 129 [28.7%] abstinence) than those who did not respond to treatment (19 of 245 [7.8%] abstinence; OR; 4.6; 95% CI, 2.5-8.6; P < .001). Conclusions and Relevance: In this randomized clinical trial of adapted vs standard of care pharmacotherapy, adaptation to varenicline and/or bupropion + NP after failure of NP monotherapy did not significantly improve abstinence rates for Black adults who smoke relative to those who continued treatment with NP. Those who achieved abstinence in the first 2 weeks of the study were significantly more likely to achieve later abstinence, highlighting early treatment response as an important area for preemptive intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03897439.

Career disruption and limitation of financial earnings due to cancer.

PURPOSE: This study investigated how cancer diagnosis and treatment lead to career disruption and, consequently, loss of income and depletion of savings. DESIGN: This study followed a qualitative descriptive design that allowed us to understand the characteristics and trends of the participants. METHOD: Patients recruited (n = 20) for this study were part of the University of Kansas Cancer Center patient advocacy research group (Patient and Investigator Voices Organizing Together). The inclusion criteria were that participants must be cancer survivors or co-survivors, be aged 18 years or older, be either employed or a student at the time of cancer diagnosis, have completed their cancer treatment, and be in remission. The responses were transcribed and coded inductively to identify themes. A thematic network was constructed based on those themes, allowing us to explore and describe the intricacies of the various themes and their impacts. RESULTS: Most patients had to quit their jobs or take extended absences from work to handle treatment challenges. Patients employed by the same employer for longer durations had the most flexibility to balance their time between cancer treatment and work. Essential, actionable items suggested by the cancer survivors included disseminating information about coping with financial burdens and ensuring that a nurse and financial navigator were assigned to every cancer patient. CONCLUSIONS: Career disruption is common among cancer patients, and the financial burden due to their career trajectory is irreparable. The financial burden is more prominent in younger cancer patients and creates a cascading effect that financially affects close family members.

Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers.

INTRODUCTION: Alternative nicotine delivery products, including electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs), contain fewer toxicants than combustible cigarettes and offer a potential for harm reduction. Research on the substitutability of e-cigarettes and HTPs is crucial for understanding their impact on public health. This study examined subjective and behavioral preferences for an e-cigarette and HTP relative to participants' usual brand combustible cigarette (UBC) in African American and White smokers naïve to alternative products. AIMS AND METHODS: Twenty-two adult African American (n = 12) and White (n = 10) smokers completed randomized study sessions with their UBC and study provided e-cigarette and HTP. A concurrent choice task allowed participants to earn puffs of the products but placed UBC on a progressive ratio schedule, making puffs harder to earn, and e-cigarette and HTP on a fixed ratio schedule to assess behavioral preference for the products. Behavioral preference was then compared to self-reported subjective preference. RESULTS: Most participants had a subjective preference for UBC (n = 11, 52.4%), followed by an equal preference for e-cigarette (n = 5, 23.8%) and HTP (n = 5, 23.8%). During the concurrent choice task, participants showed a behavioral preference (i.e., more earned puffs) for the e-cigarette (n = 9, 42.9%), followed by HTP (n = 8, 38.1%), and UBC (n = 4, 19.1%). Participants earned significantly more puffs of the alternative products compared to UBC (p = .011) with no difference in earned puffs between e-cigarettes and HTP (p = .806). CONCLUSIONS: In a simulated lab setting, African American and White smokers were willing to substitute UBC for an e-cigarette or HTP when the attainment of UBC became more difficult. TRIAL REGISTRATION: NCT04646668. IMPLICATIONS: Findings suggest that African American and White smokers are willing to substitute their UBC for an alternative nicotine delivery product (e-cigarette or HTP) when the attainment of cigarettes became more difficult in a simulated lab setting. Findings require confirmation among a larger sample under real-world conditions but add to growing evidence suggesting the acceptability of alternative nicotine delivery products among racially diverse smokers. These data are important as policies that limit the availability or appeal of combustible cigarettes are considered or enacted.

Change in E-cigarette risk perception and smoking behavior of Black and Latinx individuals who smoke.

INTRODUCTION: Trends in knowledge and beliefs about e-cigarette (EC) harm have been changing. Our study examined whether change in risk perception of ECs predicts cigarettes smoked per week (CPW) among Black and Latinx individuals who smoke enrolled in an EC switching randomized clinical trial (RCT). METHODS: We analyzed data from one arm of a 6-week EC RCT of individuals who smoke attempting to switch to nicotine salt pod system ECs (n = 110; Black, n = 57; Latinx, n = 53). Our explanatory variable was change in risk perception of ECs compared to combustible cigarettes (CC) from baseline to week 6. Our outcome was CPW measured by a 7-day timeline follow-back interview. A negative binomial GEE model was conducted to examine the association between risk perception and CPW at baseline and week 6. RESULTS: The mean CPW decreased from 82.8 (SD=49.8) at baseline to 15.8 (SD=29.8) at week 6. A one-level increase in EC risk perception (i.e., EC perceived as riskier than CC from baseline to week 6) was associated with an increase in CPW (IRR: 1.83, 95% CI: 1.03; 3.24). Latinx participants were more likely to have higher CPW as EC risk perception increased compared to Black participants (IRR=1.89, 95% CI: 1.09; 3.26). CONCLUSION: We found that CPW at week 6 was significantly higher as change in risk perception of EC relative to CC increased. Given the influence of risk perception on smoking behavior, people who smoke should be educated on the benefits and harms of ECs.

eDECIDE a web-based problem-solving interventions for diabetes self-management: Protocol for a pilot clinical trial.

Background: In the US, diabetes affects 13.2% of African Americans, compared to 7.6% of Caucasians. Behavioral factors, such as poor diet, low physical activity, and general lack of good self-management skills and self-care knowledge are associated with poor glucose control among African Americans. African Americans are 77% more likely to develop diabetes and its associated health complications compared to non-Hispanic whites. A higher disease burden and lower adherence to self-management among this populations calls for innovative approaches to self-management training. Problem solving is a reliable tool for the behavior change necessary to improve self-management. The American Association of Diabetes Educators identifies problem-solving as one of seven core diabetes self-management behaviors. Methods: We are using a randomized control trial design. Participants are randomized to either traditional DECIDE or eDECIDE intervention. Both interventions run bi-weekly over 18 weeks. Participant recruitment will take place through community health clinics, University health system registry, and through private clinics. The eDECIDE is an 18-week intervention designed to deliver problem-solving skills, goal setting, and education on the link between diabetes and cardiovascular disease. Conclusion: This study will provide feasibility and acceptability of the eDECIDE intervention in community populations. This pilot trial will help inform a powered full-scale study using the eDECIDE design.

Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial.

BACKGROUND: As the US Food and Drug Administration takes regulatory action on menthol cigarettes, debate continues about how restricting menthol e-liquids might impact adult menthol smokers in switching to e-cigarettes. METHODS: Switching patterns and e-cigarette acceptability were assessed at week 6 among 64 black and Latinx menthol cigarette smokers who used JUUL menthol (n=39) or non-menthol e-cigarettes ((n=25), primarily mint or mango) as part of a randomised switching trial. RESULTS: No clear evidence of effects was found between menthol versus non-menthol e-cigarettes on use or subjective effects/acceptability, effect sizes for all comparisons were small (effect size=0.0-0.2), and Bayes factor ranged from 0.10 to 0.15. Specifically, 82.1% of participants who used menthol-flavoured e-cigarettes fully or partially switched to e-cigarettes compared with 88.0% of participants who used a non-menthol (p=0.75). Further, both groups demonstrated substantial reductions in cigarettes per day (menthol e-cigarettes: -8.5±10.4 vs non-menthol e-cigarettes: -8.8±5.8, p=0.87), comparable grams of e-liquid consumed (menthol e-cigarettes: 9.2±9.8 g vs non-menthol e-cigarettes: 11.0±11.0 g, p=0.47), and positive subjective effects, including 'just right' throat hit (menthol e-cigarettes: 70.7% vs non-menthol e-cigarettes: 66.7%, p=0.93) and flavour liking (menthol e-cigarettes: 75.6% vs non-menthol e-cigarettes: 66.7%, p=0.32). CONCLUSIONS: Both menthol and non-menthol e-cigarettes were associated with high rates of use and acceptability among menthol smokers. Findings require confirmation in a fully powered non-inferiority or equivalence study but provide preliminary evidence to inform regulatory action on menthol e-cigarettes that could slow youth initiation without impacting black and Latinx menthol cigarette smokers interested in switching to e-cigarettes. TRIAL REGISTRATION NUMBER: NCT03511001.

Efficacy of Web-Delivered Acceptance and Commitment Therapy (ACT) for Helping Black Adults Quit Smoking.

BACKGROUND: Digital smoking cessation interventions may reduce racial disparities in cessation because they are low cost, scalable, and can provide support at any place or time. Despite their promise, whether Black adults engage with and benefit from these tools is largely unknown. In a secondary analysis of a randomized trial, we explored the efficacy of an acceptance and commitment therapy (ACT)-based website (WebQuit) for smoking cessation compared to a US clinical practice guidelines-based website (Smokefree.gov) among Black adults. METHODS: A total of 316 Black adult smokers were enrolled in the trial between May 2017 and September 2018 and received access to WebQuit or Smokefree for 12 months. Participants self-reported on 30-day and 7-day abstinence from cigarette smoking at 3, 6, and 12-months. Treatment engagement was objectively measured and compared between arms. Participants also reported on their willingness to accept cues to smoke without smoking. RESULTS: WebQuit versus Smokefree participants engaged more with their website (higher number of logins, Incidence Rate Ratio (IRR) = 2.21; 95% CI: 1.70, 2.89). Complete-case 30-day point prevalence abstinence (PPA) at 12-months was 34% for WebQuit vs. 29% for Smokefree (OR = 1.22 95% CI: 0.73, 2.04). Increases in participants' willingness to accept cues to smoke mediated the intervention effect on abstinence from cigarette smoking at 12 months. CONCLUSIONS: This study addressed the lack of research on the utilization and efficacy of digital interventions for helping Black adults quit smoking. WebQuit participants engaged more with their website and quit smoking at a somewhat higher rate relative to Smokefree participants, albeit nonsignificant. Findings suggest high acceptability of ACT-based digital interventions to enable Black adult smokers to engage and sustain behavior changes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01812278.

Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke.

Background: The standard of care in tobacco treatment is to continue individuals who smoke on the same cessation medication, even when they do not stop smoking. An alternative strategy is to adapt pharmacotherapy based on non-response. A handful of studies have examined this approach, but they have adapted pharmacotherapy only once and/or focused on adaptation distal rather than proximal to a failed quit attempt. Few studies have included racial/ethnic minorities who have less success in quitting and bear a disproportionate share of tobacco-related morbidity and mortality. Methods: The current study is comparing the efficacy of optimized (OPT) versus enhanced usual care (UC) for smoking cessation in African Americans (AA) who smoke cigarettes. AAs who smoke (n = 392) are randomized 1:1 to OPT or UC. Participants in both groups receive 7 sessions of smoking cessation counseling and18-weeks of pharmacotherapy with long-term follow-up through Week 26. OPT participants receive nicotine patch and up to two pharmacotherapy adaptations to varenicline and bupropion plus patch based on carbon monoxide verified smoking status (≥6 ppm) at Weeks 2 and 6. UC participants receive patch throughout the duration of treatment. We hypothesize that OPT will be more effective than UC on the primary outcome of biochemically verified abstinence at Week 12. Discussion: If effective, findings could broaden the scope of tobacco dependence treatment and move the field toward optimization strategies that impro ve abstinence for AA who smoke. Trial registration: NCT03897439.

The Role of Financial Strain and Educational Attainment on Smoking Abstinence of African Americans and Whites Who Smoke.

Objective: To examine if reduced financial strain and higher educational attainment would confer less advantage for successful cessation among African Americans than for White individuals. Design: A secondary data analysis of the Quit2Live study, a smoking cessation intervention for individuals who smoke. Setting: Recruited participants from a metropolitan city in the Midwest. Participants: The sample included 224 African American and 225 White individuals who smoke. Main Outcome Measures: Our outcome variable was cotinine-verified smoking abstinence at the end-of-treatment (week 12). Our explanatory variables were a combination of financial strain (high, low) and educational attainment (high, low). Methods: We implemented a logistic regression analysis and a two-way interaction of the combined financial strain and educational attainment variable and race on smoking abstinence. Results: About 25% of the study participants were low financial strain and high education, 41% high financial strain and high education, 23% high financial strain and low education, and 11% low financial strain and low education. A greater proportion of African Americans vs Whites were in the high financial strain/low educational attainment category (28% vs 18%, P = .01). Participants with high financial strain and low educational attainment had substantially lower odds of abstinence (OR = .29 [95% CI: .12, .68]) compared to participants with low financial strain and high educational attainment. Contrary to our hypothesis, race did not moderate this association. Conclusion: Findings highlight the constraining role of high financial strain and low educational attainment, irrespective of race, on smoking abstinence among smokers actively engaged in a quit attempt.

Quitting Smoking before and after Pregnancy: Study Methods and Baseline Data from a Prospective Cohort Study.

Smoking during pregnancy and postpartum remains an important public health problem. No known prior study has prospectively examined mutual changes in risk factors and women's smoking trajectory across pregnancy and postpartum. The objective of this study was to report methods used to implement a prospective cohort (Msgs4Moms), present participant baseline characteristics, and compare our sample characteristics to pregnant women from national birth record data. The cohort study was designed to investigate smoking patterns, variables related to tobacco use and abstinence, and tobacco treatment quality across pregnancy through 1-year postpartum. Current smokers or recent quitters were recruited from obstetrics clinics. Analyses included Chi-square and independent sample t-tests using Cohen's d. A total of 62 participants (41 smokers and 21 quitters) were enrolled. Participants were Black (45.2%), White (35.5%), and multiracial (19.3%); 46.8% had post-secondary education; and most were Medicaid-insured (64.5%). Compared with quitters, fewer smokers were employed (65.9 vs 90.5%, Cohen's d = 0.88) and more reported financial strain (61.1% vs 28.6%; Cohen's d = 0.75). Women who continue to smoke during pregnancy cope with multiple social determinants of health. Longitudinal data from this cohort provide intensive data to identify treatment gaps, critical time points, and potential psychosocial variables warranting intervention.

Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial.

Importance: African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels. Objectives: To evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers. Design, Setting, and Participants: The Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018. Interventions: Participants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]). Main Outcomes and Measures: The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d). Results: Among 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]). Conclusions and Relevance: Among African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers. Trial Registration: ClinicalTrials.gov Identifier: NCT02360631.

The effect of race/ethnicity and adversities on smoking cessation among U.S. adult smokers.

INTRODUCTION: Black and Hispanic individuals in the US experience more socioeconomic adversities that are associated with disparities in tobacco use and cessation than White individuals. This study examined if racial/ethnic differences in smoking abstinence were mediated by socioeconomic (SES) adversities. METHODS: Data from 7,101 established smokers were identified in Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health (PATH) and followed to Wave 4 (2016-2018). The study outcome was cigarette abstinence at Wave 4. The main independent variable was race/ethnicity (Non-Hispanic White [White], Non-Hispanic Black [Black] and Hispanic). The mediators were five measures of SES adversities (unemployment, poverty, difficulty with money, lower education level, lack of health insurance). A weighted Generalized Structural Equation Model (GSEM) was used to estimate the total, direct, and indirect effect of race/ethnicity on the odds of quitting mediated by the five SES adversities. This model was adjusted by study covariates, including health and smoking characteristics. RESULTS: The indirect effect of race/ethnicity on cessation showed that differences in quitting between Black and White individuals as well as Hispanic and White individuals were mediated by SES adversities. However, the differences in quitting between Hispanic and Black individuals were not mediated by SES adversities. Black and Hispanic individuals were less likely to quit than White individuals, but Hispanic individuals were more likely to quit than Black individuals. There were no direct effects between Black or Hispanic individuals compared to White individuals. Those with higher SES were more likely to quit compared to those with lower SES. DISCUSSION: Smoking abstinence is higher in White individuals compared to Black and Hispanic individuals and is mediated by SES adversities. However, smoking abstinence is higher among Hispanic individuals compared to Black individuals and it is not mediated by SES adversities. Future studies should consider the role of other factors, such as psychosocial support, racism, discrimination, and stress over the life course in explaining differences in smoking abstinence between Black and Hispanic individuals.

The impact of COVID-19 on income and employment and willingness to become vaccinated among African Americans enrolled in a smoking cessation randomized trial.

Given vulnerability to COVID-19 among smokers and vaccine hesitancy among populations disproportionately burdened with COVID-19, it's important to understand concerns about vaccines and the impact of COVID-19 on these subgroups. Among our all African American (AA) sample of smokers (N = 172) enrolled in alargersmoking cessation clinical trial, results demonstrated an intensive burden from COVID-19; 42 (24.4%) lost employment, 56 (32.6%) lost household income, and 66 (38.4%) reportedinability to pay bills and buy food due to COVID. Most, 103 (64.4%), were willing to get vaccinated. Among the vaccine-hesitant, 57 (35.6%), concerns about COVID-19 vaccine development and mistrust in vaccines were primary reasons for unwillingness to get vaccinated. Few identified doctor's advice as most valued in deciding if the vaccine was the best option. Findings highlight high openness to the vaccine among smokers impacted by COVID but reiterate the need for community-engaged versus health system-driven approaches to improve vaccine hesitancy among racial/ethnic minorities.

Effects of Marijuana Use on Smokers Switching to E-Cigarettes in a Randomized Clinical Trial.

INTRODUCTION: Co-use of tobacco and marijuana is common, and research suggests that marijuana use may be a barrier to smoking cessation. Research to date has not evaluated how marijuana use affects e-cigarette switching behaviors and related outcomes in a harm reduction trial. AIMS AND METHODS: This secondary analysis includes African American (48%) and Latinx (52%) adult smokers randomized to the e-cigarette group (N = 114) of a harm reduction clinical trial from 2018 to 2019. Participants were provided JUUL e-cigarettes and encouraged to make an exclusive switch for 6 weeks. Our primary outcome was cigarettes smoked per week. Secondary health outcomes were e-cigarette substitution (calculated by measuring e-cigarette pod use), expired carbon monoxide (CO), and respiratory symptoms. Marijuana products were recorded at three timepoints and coded for combustion. RESULTS: Marijuana use during the study (n = 52, 46%) was not associated with week 6 cigarettes smoked or e-cigarette substitution, and combustible marijuana use was not associated with week 6 respiratory symptoms (ps > .05). After controlling for cigarettes smoked at week 6, combustible marijuana use was significantly associated with a 4.4 ppm increase in CO compared with no use of marijuana (p = .001). CONCLUSIONS: Marijuana use was not a barrier to switching to e-cigarettes in this 6-week trial. Marijuana use contributed to elevated CO, reflecting greater exposure to toxic combustion products, beyond the effects of cigarette smoking. Marijuana co-use may increase risk of adverse health outcomes and may be a confounding factor when using CO as an endpoint to bioverify exclusive e-cigarette use. IMPLICATIONS: This is the first known study to examine the effects of marijuana use on smokers switching to e-cigarettes. Marijuana use was not a barrier to cigarette reduction in a 6-week randomized clinical trial. Marijuana use uniquely contributed to higher carbon monoxide among cigarette smokers, indicating greater exposure to toxic combustion products, which could increase risk of adverse health outcomes. Furthermore, combustible marijuana use may be a confounding factor when CO is used as an endpoint to bioverify exclusive e-cigarette use.